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New study investigates hidden heart risks in cystic fibrosis patients on modern drugs

NCT ID NCT07692594

Knowledge-focused Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study looks at whether people with cystic fibrosis (CF) who take newer modulator drugs are developing heart disease. Researchers will use ultrasound to measure blood vessel and heart health, then repeat the tests a year later to see how things change. They will also check if standard heart-risk prediction tools work for people with CF. The goal is to find who is at highest risk so that future studies can test early prevention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could help identify which people with cystic fibrosis are at highest risk for heart disease, paving the way for early prevention strategies.
What could go wrong
This is a small observational study (32 participants) that measures changes over one year. It may not capture long-term risks or apply to all people with CF.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with CF will be recruited from the CF outpatient clinic at Liverpool Heart and Chest Hospital (face-to-face and telemedicine clinic). The study will be advertised in local GP practices and NHS trust notice boards, and contact information will be provided on the advertisements for prospective healthy controls to approach a member of the clinical-research team.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed diagnosis of cystic fibrosis, based on sweat chloride testing and/or CFTR genotyping * Aged 18 years or older * Currently receiving CFTR gene modulators, defined as elexacaftor/ tezacaftor/ ivacaftor (ETI), or any next generation gene modulators after ETI, introduced for at least 3 months * On licensed doses that is listed on Summary of Product Characteristics of each CFTR gene modulator. * Clinically stable at the time of assessment (no pulmonary exacerbation or hospitalisation in the past 4 weeks) Inclusion Criteria for healthy control: • Clinically stable at the time of assessment (no pulmonary exacerbation or hospitalisation in the past 4 weeks) Exclusion Criteria: * On long term steroids, or any vasoactive medications * Diagnosed with end stage organ diseases * Diagnosed with rheumatoid arthritis, and/or systemic lupus erythematosus * Pregnancy or breastfeeding * are a smoker, or have been smoking in the last 10 years * Inability to undergo vascular assessments (e.g. upper limb vascular anomalies, limb injury) * Inability to comply with fasting instructions (for blood draws) * Had an organ transplantation

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular (CV) risk Cystic fibrosis (CF) Flow-mediated dilation evaluation of the brachial artery Pulse wave analysis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE, United Kingdom

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